Trial Outcomes & Findings for Laser Therapy for Treatment of Urogenital Symptoms in Women (NCT NCT03681678)
NCT ID: NCT03681678
Last Updated: 2025-12-23
Results Overview
PGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement.
COMPLETED
100 participants
4 weeks post-initial treatment
2025-12-23
Participant Flow
Participant milestones
| Measure |
fCO2 Laser Therapy Group
Women treated with the fCO2 laser
fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
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|---|---|
|
Overall Study
STARTED
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100
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
fCO2 Laser Therapy Group
Women treated with the fCO2 laser
fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
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|---|---|
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Overall Study
Lost to Follow-up
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20
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Baseline Characteristics
Laser Therapy for Treatment of Urogenital Symptoms in Women
Baseline characteristics by cohort
| Measure |
fCO2 Laser Therapy Group
n=80 Participants
Women treated with the fCO2 laser
fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
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66 Participants
n=68 Participants
|
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Age, Categorical
>=65 years
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14 Participants
n=68 Participants
|
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Sex: Female, Male
Female
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80 Participants
n=68 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
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Region of Enrollment
United States
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80 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-initial treatmentPGI-I score is recorded 4 weeks after initial treatment completion. The PGI-I asks the patient to "check the box that best describes how your urinary and/or vaginal symptoms are now, compared with how you symptoms were before you began this study." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better", 2 is "Much Better, 3 is "A Little Bit Better", 4 is "No Change", 5 is "A Little Worse", 6 is "Much Worse", and 7 is "Very Much Worse". A score from 1 to 3 would indicate improvement.
Outcome measures
| Measure |
fCO2 Laser Therapy Group
n=80 Participants
Women treated with the fCO2 laser
fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
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|---|---|
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Patient Global Impression of Improvement (PGI-I) Score at 4 Weeks After Initial Treatment
|
2.66 score on a scale
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe average change in patients' PGI-I scores from baseline to 6 months and 36 months post-treatment. The PGI-I asks the patient to "check the one number that best describes how your urinary tract condition is now compared with how it was before your treatment." There are 7 possible responses ranging from 1 to 7, where 1 is "Very Much Better" and 7 is "Very Much Worse". A lower score would represent improvement and a favorable outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe Vaginal Health Inventory Score (VHIS) is an assessment tool, used by providers, to determine if vaginal atrophy is present. Providers perform a vaginal exam and give a score of 1-5 (abnormal to normal, respectively) on each of the following vaginal parameters: elasticity, secretion/fluid volume, vaginal pH, integrity of the epithelium, and lubrication/moisture of the vaginal wall. A VHIS score less than 15 is indicative of vaginal atrophy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentPatients will complete the QUID, which consists of 6 questions. Responses to the questions indicate the frequency of urinary incontinence. Scores are: 0 (none of the time), 1 (rarely), 2 (once in awhile), 3 (often), 4 (most of the time), or 5 (all of the time). Responses to items 1, 2, and 3 are summed for the Stress Urinary Incontinence Score. Responses to items 4, 5, and 6 are summed for the Urge Incontinence Score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HR-QOL) in patients with OAB. Each question is rated on a 6 point scale with 1 = Not at all and 6 = A very great deal.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentA 3-day voiding diary will be completed by the patient and evaluated to describe urinary frequency and incontinence episodes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe FSFI consists of 6 subscales related to sexual desire (2 Qs scale 1 worst - 5 best), arousal (4Qs 0 worst - 5 best), lubrication (4Qs 0 worst-5 best), orgasm (3Qs 0 worst - 5 best), satisfaction ( 3Qs 0 worst - 5 best), and pain (3 Qs 0 worst - 5 best). Higher scores indicate higher sexual functioning. Scores range from 2-36. A score of 26.55 has been clinically selected as the cut-off for sexual dysfunction. Scores below this value indicate sexual dysfunction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentA clean catch urine specimen will be collected at each visit. A positive urine dipstick test will have the presence of leukocytes and nitrites accompanied by symptoms (dysuria, bladder pain, and/or urinary frequency).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe GAD-7 is a self-reported questionnaire for screening and measuring severity of generalized anxiety disorder. There are 7 questions total, each answer is scored on a scale from 0 = not at all to 3 = nearly every day. Scores greater than or equal to 10 indicate moderate anxiety and further assessment is recommended.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe PHQ-8 is an eight item questionnaire that is a valid diagnostic and severity measure for depressive disorders. Each question is scored from 0 = not at all to 3 = nearly every day. A score of 10 or greater is considered major depression and a score of 20 or more as severe major depression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentThe Incontinence Quality of Life Questionnaire (I-QOL) is a validated tool to assess the impact of urinary incontinence problems. The I-QOL has 22 incontinent-specific quality of life items all having the following five-point ordinal response scale: 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. Total I-QOL is a combined score of all items. All 22 items are summed to calculate a total I-QOL score, ranging from 22 to 110, with a high score indicating a better quality of life. The 22 items are broken down into 3 subscales: Avoidance and Limiting Behaviors Score (8 of the 22 items), Psychosocial Impacts Score (9 of the 22 items), and Social Embarrassment Score (5 of the 22 items). Scores are summed based on the same 5-point scale. 1= Extremely, 2= Quite a Bit, 3= Moderately, 4= A Little, and 5= Not at All. A high score indicates a better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months and 36 months post-initial treatmentPresence or absence of lactobacillus will be collected by the physician via a vaginal swab and assessed under the microscope.
Outcome measures
Outcome data not reported
Adverse Events
fCO2 Laser Therapy Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
fCO2 Laser Therapy Group
n=80 participants at risk
Women treated with the fCO2 laser
fCO2 Laser Therapy Group: Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
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|---|---|
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Infections and infestations
Urinary Tract Infection
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10.0%
8/80 • Number of events 11 • 3 years
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Reproductive system and breast disorders
vaginal pain
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1.2%
1/80 • Number of events 1 • 3 years
|
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Infections and infestations
Vaginal yeast infection
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5.0%
4/80 • Number of events 4 • 3 years
|
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Reproductive system and breast disorders
Vaginal Burning
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2.5%
2/80 • Number of events 3 • 3 years
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Renal and urinary disorders
Urethral mass
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1.2%
1/80 • Number of events 1 • 3 years
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Renal and urinary disorders
Bladder pressure
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1.2%
1/80 • Number of events 1 • 3 years
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Musculoskeletal and connective tissue disorders
Flank pain
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1.2%
1/80 • Number of events 1 • 3 years
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Renal and urinary disorders
Dysuria
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1.2%
1/80 • Number of events 1 • 3 years
|
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Renal and urinary disorders
Increase urinary urgency
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5.0%
4/80 • Number of events 4 • 3 years
|
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Reproductive system and breast disorders
Vaginal infection - not specified
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
ovarian cysts
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1.2%
1/80 • Number of events 1 • 3 years
|
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Renal and urinary disorders
positive urine dipstick
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1.2%
1/80 • Number of events 2 • 3 years
|
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Infections and infestations
Bacterial vaginosis
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6.2%
5/80 • Number of events 6 • 3 years
|
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Injury, poisoning and procedural complications
Pain during treatment
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2.5%
2/80 • Number of events 5 • 3 years
|
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Renal and urinary disorders
Suspected urinary calculus
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1.2%
1/80 • Number of events 1 • 3 years
|
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Infections and infestations
Suspected bacterial vaginosis
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1.2%
1/80 • Number of events 1 • 3 years
|
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Injury, poisoning and procedural complications
Discomfort with probe insertion
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5.0%
4/80 • Number of events 4 • 3 years
|
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Reproductive system and breast disorders
Vaginal burning during treatment
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6.2%
5/80 • Number of events 5 • 3 years
|
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Musculoskeletal and connective tissue disorders
Flare of pelvic floor muscle
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1.2%
1/80 • Number of events 3 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash - Allergic reaction to Cipro
|
1.2%
1/80 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Worsening dyspareunia
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Vaginal itching
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3.8%
3/80 • Number of events 4 • 3 years
|
|
Reproductive system and breast disorders
Vaginal irritation
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Nervous system disorders
Numbness to lower extremity and buttock
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1.2%
1/80 • Number of events 2 • 3 years
|
|
Reproductive system and breast disorders
Exacerbation of vaginal atrophy
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Left labial itching and redness
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Trauma to introitus during treatment
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Renal and urinary disorders
Proteinuria
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Nervous system disorders
Pudendal nerve pain
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1.2%
1/80 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
8.8%
7/80 • Number of events 8 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place